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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K203685
Device Name Disposable Surgical Face Mask
Applicant
Xiantao Zhongyi Safety & Protection Products Co., Ltd.
#101, Xianyuan Rd.
Xiantao,  CN 433000
Applicant Contact Yang Xi
Correspondent
Shanghai Sungo Management Consulting Company Limited.
13th Floor, 1500# Central Ave.
Shangghai,  CN 200122
Correspondent Contact Mandy Wu
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/17/2020
Decision Date 03/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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